- United Therapeutics (Silver Spring, MD)
- …and pulmonary diseases, and other orphan diseases. **How you'll contribute** The Senior Regulatory Affairs Manager partners with senior regulatory ... regulatory submissions and department activities. This role serves as a Regulatory Affairs representative on project teams, interpreting issues and advising… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Senior Manager - Regional Regulatory Lead** **Live** ... do** Let's do this. Let's change the world. The Regulatory Affairs Senior Manager at... regulatory strategies. **Responsibilities:** + Implement the US regulatory plan and obtain and maintain Clinical … more
- Veterans Affairs, Veterans Health Administration (Washington, DC)
- …updates policies and procedures and establishes and oversees a system for regulatory compliance. Coordinates food service operation policies and procedures with ... clinical nutrition management, nursing and other services, as applicable....program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Participation in the Coronavirus… more
- Amgen (Washington, DC)
- …of more senior staff. **Responsibilities:** + Support biostatistical activities for Clinical Development, Clinical Operations, Medical Affairs , and ... response technology (IxRS) specifications + Collaborate with project management, regulatory , medical affairs , PV/safety, business development, and commercial… more
- Edwards Lifesciences (Washington, DC)
- …our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for ... clinical trials with skill levels exceeding the requirements of the Associate Manager Required + Experience in clinical trial design, indication lead +… more
- Amgen (Washington, DC)
- …the lives of patients while transforming your career. **Global Advocacy Relations Senior Manager (Oncology)** **What you will do** Let's do this! Let's change the ... world! In this vital role, the Oncology Senior Manager of Global Advocacy Relations at Amgen is responsible...focused solutions in the design and development of our clinical development programs + Creates engagement opportunities for patients… more
- Amgen (Washington, DC)
- …and US Medical, US Business Units, Global Product Teams, Government Affairs , Healthcare Policy, Clinical Development, Health Economics/Outcomes Research, Value ... transform the lives of patients while transforming your career. **Advocacy Relations Senior Manager , Bone Health** **What you will do** Let's do this! Let's change… more
- Fujifilm (Washington, DC)
- …+ Proven track record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging ... US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all...at least 1-2 years direct experience as a Product Manager within HCUS/MIPD + Strong understanding of clinical… more
- Amgen (Washington, DC)
- …more years of expertise in clinical research, patient care, Clinical Development, Medical/Scientific Affairs , and/or basic research (other doctorate degrees ... may be considered) + Prior experience in Medical/Scientific Affairs or Clinical Development within the biopharmaceutical industry, and/or clinical or… more
- Catalent Pharma Solutions (Harmans, MD)
- …plans. This position reports directly to the Senior Vice President of Quality & Regulatory Affairs and will have strong working relationships with VP General ... accountable for ensuring the successful delivery of quality and regulatory strategy and operational performance for the Maryland campus....Manager Maryland and other Site Leadership team members. Working… more
- Koniag Government Services (Silver Spring, MD)
- …+ Certifications or specialized training in areas such as medical writing, regulatory affairs , or scientific communication + Strong presentation and public ... via email only and have not been interviewed by the KGS hiring manager , feel free to contact_ _KGSrecruiting@koniag-gs.com_ _to verify its validity._ **Koniag IT… more
- CSL Plasma (Halethorpe, MD)
- …Staff Associates for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides ... appropriate physician the duties of "laboratory director", "technical consultant", or " clinical consultant" as prescribed by the Clinical Laboratory Improvement… more